Device Classification Name |
rod, fixation, intramedullary and accessories
|
510(k) Number |
K160167 |
Device Name |
DePuy Synthes TFNA Augmentation System |
Applicant |
Synthes (USA) Products, LLC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Applicant Contact |
Christopher J. Medberry |
Correspondent |
Synthes (USA) Products, LLC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Correspondent Contact |
Christopher J. Medberry |
Regulation Number | 888.3020
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/27/2016 |
Decision Date | 09/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|